Effects of low-dose methotrexate with MMI in patients with Graves' disease: results of a randomized clinical trial
Abstract
CONTEXT
Supplemental methotrexate (MTX) may affect the clinical course of Graves' disease (GD).
OBJECTIVE
Evaluate efficacy of add-on MTX on medical treatment in GD.
DESIGN
Prospective, open-label, randomized supplementation controlled trial.
SETTING
Academic endocrine outpatient clinic.
PATIENTS
One hundred and fifty-three untreated hyperthyroid patients with GD.
INTERVENTION
Patients received MTX 10 mg/d with methimazole (MMI) or MMI only. MTX and MMI were discontinued at months 12-18 in euthyroid patients.
MAIN OUTCOME MEASURES
Discontinuation rate at months 18 in each group.
RESULTS
In the MTX with MMI group, the discontinuation rate was higher than the MMI group at months 15-18 (50.0 vs. 33.3%, P=0.043, 95% CI 1.020 to 3.922; and 55.6 vs 38.9%, P=0.045, 95%CI 1.011 to 3.815, respectively). The decrease in TRAb levels in the MTX with MMI group was significant from baseline to months 6 compared to the MMI alone group [MTX+MMI 67.22% (43.12-80.32), MMI 54.85% (33.18-73.76), P= 0.039) and became more significant from months 9 [MTX+MMI 77.79% (62.27-88.18), MMI 69.55% (50.50-83.22), P= 0.035] to months 18 (P < 0.01 in 15-18 months). A statistically significant difference between the levels of TRAb in the MTX with MMI group and the MMI group at 9-18 months. There were no significant differences in the levels of FT3, FT4 and TSH between two groups. No serious drug-related adverse events were observed in both groups(P=0.771).
CONCLUSIONS
Supplemental MTX with MMI resulted in…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 18 participants or records.
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